MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732052

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 01/19/2022

Event Type  Injury  

Event Description

The patient was revised due to pain.Doi: (b)(6) 2018.Dor: (b)(6) 2022.Right hip.

Manufacturer Narrative

Product complaint # :(b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot; the device lot number is unknown, therefore a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.

Event Description

Medical records received.On (b)(6) 2018 the patient had a right total hip arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure.On (b)(6) 2022 the patient had a revision right total hip arthroplasty to address the dislodgment of modular acetabular polyethylene insert due to impingement of the prosthetic neck on the polyethylene insert.Indications for surgery included, the patient feeling a clunk in her right hip.The surgeon reported finding that the liner dislodged from the cup.There was some titanium wear debris on the superior aspect of the ceramic femoral head.Head/liner were revised.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D10.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

Medical records ad 22 jan 2024 were reviewed by a clinician.Multiple clinic visits reported of medical issues not related to jnj implants.On (b)(6) 2022 the physician does note that the left leg is longer than the right.There are also notes that indicate the patient was having residual pain after her revision however further notes indicate this has resolved without further intervention.No further pcs will be created at this time as pain after a revision is to be expected.

Manufacturer Narrative

Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2018 the patient had a right total hip arthroplasty to address osteoarthritis and pain.Depuy components were implanted during this procedure.The patient reports worsening global right hip pain.On (b)(6) 2018, medical records note the patient had right hip pain and a fall.The patient was injected with toradol for pain.On (b)(6) 2020 medical records note the patient has right hip contusion, and back pain, with sciatica symptoms.On (b)(6) 2022 the patient had a revision right total hip arthroplasty to address the dislodgment of the modular acetabular polyethylene insert due to impingement of the prosthetic neck on the polyethylene insert.Before surgery, the patient reported pain, limited range of motion, and felt their hip ¿roll out of place¿ and an audible squeak.Indications for surgery included, the patient feeling a clunk in her right hip.The surgeon reported finding that the liner dislodged from the cup.There was some titanium wear debris on the superior aspect of the ceramic femoral head.Head/liner were revised.Depuy pinnacle mom liners with +4 head for her 52 mm cup were implanted during this procedure.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN SECTOR W/GRIPTION 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17876744
• MDR Text Key: 324990283
• Report Number: 1818910-2023-20279
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010302
• UDI-Public: 10603295010302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121732052
• Device Lot Number: HN3619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 10/06/2023; 12/15/2023; 01/02/2024; 01/22/2024; 01/29/2024
• Supplement Dates FDA Received: 10/08/2023; 10/11/2023; 12/21/2023; 01/24/2024; 01/26/2024; 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX52OD.; ALTRX NEUT 32IDX52OD.; CORAIL AMT COLLAR SIZE 10.; DELTA CER HEAD 12/14 32MM +1.; DELTA CER HEAD 12/14 32MM +1.; UNK HIP FEMORAL HEAD CERAMIC.; UNKNOWN HIP ACETABULAR LINERS.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White